- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05315440
The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Range of Motion After Arthroscopic Cuff Repair. (GRA-RCR)
July 17, 2025 updated by: Istituto Ortopedico Rizzoli
The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Shoulder Range of Motion After Arthroscopic Cuff Repair.
In shoulder rehabilitation after arthroscopic cuff repair, one of first objectives coincides with improving the range of passive movement: this process often requires considerable time of both patients and physiotherapists.
This study aims to verify whether it is useful to add instruments assisted soft-tissue mobilization according to Graston Tecnique to the classic rehabilitation protocol in order to accelerate recovery times of passive range of motion.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There is conflicting evidence about early versus delayed postoperative rehabilitation after arthroscopic cuff repair: early protocol seems to reduce the risk of stiffness but could increase the risk of rupture of the tendon in long time, especially for large tears; delayed protocol impose a period of shoulder immobilization (from 2 weeks to 40-day) that can promote tendons healing but could determine shoulder stiffness.
Our research question is if after the delayed protocol used in our institute (40 -day immobilization period) it migh be useful to add soft-tissue mobilization assisted by instruments according to Graston Tecnique to the classic rehabilitation protocol of the shoulder in order to speed up recovery times of the passive movement range.
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
BO
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Bologna, BO, Italy, 40136
- Istituto Ortopedico Rizzoli
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- arthroscopic rotator cuff repair
- partial lesion due to tendon degeneration (1 or 2 anchors reparation)
Exclusion Criteria:
- traumatic tendon lesions
- associated conditions as arthritis, loss of superficial sensitivity, loss of muscle tone, mental impairment, oncological conditions
- shoulder stiffness before surgery due to calcific tendonitis, adhesive capsulitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
The treatment of control group will be organized according to the classic protocol currently in use in our Institute which consists of: 30 minutes of passive and active assisted mobilization guided by the therapist, 30 min of Continous passive movement in flexion and abduction and 30 minutes of electrostimulation. |
30 minutes of passive and active assisted mobilization guided by the therapist, 30 min of Continous passive movement in flexion and abduction and 30 minutes of electrostimulation.
|
|
Experimental: experimental group
30 minutes of passive and active assisted mobilization guided by the therapist associated with instrument assisted soft tissue mobilization, 30 min of Continous passive movement in flexion and abduction and 30 minutes of electrostimulation.
|
Graston technique involves the use of steel tools that are used non-invasively on the skin to identify and treat areas that have stiffness or inflammation.
These areas can be located with greater precision than the manual technique precisely because the instruments do not compress in contact with the patient's skin, as is the case with the physiotherapist's fingertips.
Thanks to the instruments it is therefore possible to detect the areas of altered consistency and to treat them by pressing a minimum pressure.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Passive Range of Motion Recovery of the Shoulder
Time Frame: after 2 weeks of treatment
|
Passive Range of Motion Recovery of the Shoulder in elevation and abduction measured by digital inclinometer
|
after 2 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction of pain measured by Visual Analogue Scale (VAS)
Time Frame: after 2 weeks of treatment
|
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain.
Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain").
|
after 2 weeks of treatment
|
|
Shoulder function improvement measured by Constant Murley and Dash scales
Time Frame: after 2 weeks of treatment
|
The Constant-Murley score is a 100-points scale composed of a number of individual parameters that define the level of pain and the ability to carry out the normal daily activities of the patient.
The test is divided into 4 subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion (40 points).
The higher the score, the higher the quality of the function.
Since the test is carried out in an acute post-surgery phase, it is not possible to carry out the evaluation of strength, which is assigned a score of zero for all patients.
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities.
This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.The score ranges from 0 (no disability) to 100 (most severe disability).
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after 2 weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2020
Primary Completion (Actual)
January 31, 2025
Study Completion (Actual)
February 21, 2025
Study Registration Dates
First Submitted
September 14, 2021
First Submitted That Met QC Criteria
March 29, 2022
First Posted (Actual)
April 7, 2022
Study Record Updates
Last Update Posted (Actual)
July 18, 2025
Last Update Submitted That Met QC Criteria
July 17, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0002771
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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